A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement

ISRCTN	ISRCTN58128724
DOI	https://doi.org/10.1186/ISRCTN58128724
Secondary identifying numbers	7766

Submission date: 24/06/2010
Registration date: 24/06/2010
Last edited: 01/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Sukumaran Nair
Scientific

Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Study information

Study design	Single-centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement
Study acronym	MiniStern Trial
Study objectives	MiniStern is a pragmatic, prospective randomised controlled trial comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).
Ethics approval(s)	MREC approved (ref: 09/H0301/58)
Health condition(s) or problem(s) studied	Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Surgery
Intervention	Comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).
Intervention type	Procedure/Surgery
Primary outcome measure	Total length of stay in hospital for the index AVR operation measured in days
Secondary outcome measures	1. Fitness for discharge 2. Health related quality of life and patient satisfaction at baseline, 6 weeks, 6 months and 12 months using the 36-item short form health survey (SF-36) and Coronary Revascularization Outcome Questionnaire - Coronary Artery Bypass Graft (CROQ-CABG) 3. Heart function (LVEF) by echocardiography at baseline, day of discharge and 6 months post surgery 4. Procedure time: total theatre time, cross clamp time, cardiopulmonary bypass time, blood loss, blood transfusion 5. Respiratory function (forced expiratory volume in one second [FEV1]) by hand held spirometry at baseline, day 4, day of discharge, 6 weeks and 6 months
Overall study start date	30/11/2009
Completion date	01/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 240
Total final enrolment	222
Key inclusion criteria	1. Aged greater than 18 years at the time of surgery, either sex 2. Elective, first time, isolated aortic valve replacement (AVR)
Key exclusion criteria	1. Documented poor left ventricular (LV) function or left ventricular ejection fraction (LVEF) 30% 2. Documented chest wall deformities 3. Documented severe emphysema or chronic obstructive pulmonary disease (COPD) 4. Current body mass index (BMI) greater than 35 kg/m^2 5. Concomitant cardiac surgery 6. Redo surgery 7. Median sternotomy indicated
Date of first enrolment	30/11/2009
Date of final enrolment	01/09/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Papworth Hospital NHS Foundation Trust

Cambridge
CB23 3RE
United Kingdom

Sponsor information

Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom

Website	http://www.papworthhospital.nhs.uk/index.php
"ROR"	https://ror.org/01qbebb31

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2018	01/10/2019	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

01/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.